CAP offers voluntary standards for nontraditional test sites After
eight months of polishing and fine tuning, the College of American
Pathologists has completed a report it will now submit to industry
dialog on laboratory testing at nontraditional sites. The effort could
ultimately sway Washington's decision as to whether the industry
can regulate itself--or if it needs help.

By April, the Health Care Financing Administration is to report to
Congress on possible standards for physicians' office laboratories.
The agency is currently collecting data for that report, but sources
indicate that enthusiasm for the project is minimal.

HCFA officials have stated that they prefer industry initiatives to
the long arm of the law. An office within the agency is charged with
collecting information on what tests are being performed in-office,
which personnel run the tests, and how they generally perform. The
queries are typical of Government investigations into perceived trouble
spots.

Bureaucrats are closely monitoring efforts such as CAP's and
the intersociety Committee on Office Laboratory Assessment (COLA). The
latter group is getting off the ground with a pilot project featuring a
self-inspection "checklist" that will allow doctors to compare
their facilities and procedures with a common standard. Some 40
laboratories are said to be participating in the project to define
elements in a quality assurance, education, and assessment program.
COLA expects to emerge with some certification criteria for physician
laboratories.

The CAP report, which becomes available publicly this month, draws
on the findings of some 200 leading pathologists who gathered for a
series of meetings in Atlanta last April. Attendees broke up into five
working groups to explore issues in definition of terms, analytical
performance criteria, legal and regulatory issues, performance
assessment, and procedural selection.

The following is excerpted from the working groups'
"inferences and recommendations." Complete findings are
available in the report, which also includes manuscripts on the
different topics, question and answer discussions, summaries, and
bibliographies. For a copy ($49.95), call CAP at (312) 966-5700.

* Definition of terms. Essentially unchanged from earlier drafts,
this group presents some basic definitions for testing in
non-traditional sites. Specifically, physician office testing should
ideally "be organized to provide timeliness in response to
diagnosis, monitoring, or change in treatment and facilitate the
promotion of improved physician-patient relationships within the
precepts of providing adequate quality assurance and economics of
operation."

Bedside testing is deemed to be lab testing provided in close
proximity to the patient, and organized to give immediate, clinically
reliable results that initiate, direct, or modify therapy. It should be
performed by health care providers under direction of physician in an
institution or the home.

One earlier version defined home testing as being performed by a
lay person without "the resources of a laboratory nor the
technical, medical, or scientific expertise." In the final report,
the term "expertise" is dropped and replaced with
"training ordinarily involved in the testing and use of information
provided.

An added recommendation says home testing should only be performed
if it has medical usefulness to a doctor in diagnosing, screening, or
monitoring a health problem with no potential danger to public health,
and if it doesn't subvert reporting requirements for dangerous
communicable diseases.

* Legal and regulatory. Filing the lenthiest list of
recommendations, this work group offers its acceptable regulatory
criteria for physician office labs. It concludes that regulation should
be voluntary, as through COLA, and should involve proficiency testing and pathologist consultation. Noting the difficulties with regulating
the large number of office labs, thereport says on-site inspection and
personnel requirements should not be necessary.

The role of consulting pathologists in the physician lab covers the
selection of procedures and instrumentation, establishment of quality
control, and ongoing personnel instruction/training.

Regarding licensure of clinical laboratories (hospital and
independent), the panel notes: "Requirements vary from state to
state and set a floor, not a ceiling." Rules may include criteria
for personnel (education, experience, and responsibilities) and
successful participation in external proficiency testing. On-site
inspection may also be included.

In an added section on professional negligence, the report finds
that malpractice "is the commission or omission of an act within a
professional setting." Elements of negligence must be proved
"preponderant," and include the duty of care owed, breach of
care standards, nature of injury, proximate causation, and extent of
damage. "Abandonment" can be construed if a pathologist is
absent from an off-site lab and a problem ensues.

* Analytical performance criteria. In a new foreword to findings
drafted at the conference, this group comments:

"Analytic performance within limited-function laboratories and
the home can be expected to evolve and improve over time. Present
performance needs to be assessed. Improvement toward desirable analytic
goals must be promoted by ongoing educational efforts."

Among the panel's standing findings are that goals for
analytic accuracy should be the same in all testing sites. It is
advised that goal specification "is dependent on the intended
clinical application of the test. Goals may vary in stringency for a
given analyte. Laboratories should select methods and instruments that
best meet the analytical demands of intended clinical use."

In a more recent recommendation, this work group concludes:
"The goal-setting process for tests of identification differs from
that for tests of quantitation. Both should be based on the intended
clinical use."

Further, "Performance assessment methods for limited-function
laboratories should be the same as for central laboratories. Performance
assessment of home diagnostics will differ from the traditional methods
of internal and external central laboratory quality control. However,
the goals for accuracy of home diagnostics should be the same as for
testing in other sites."

* Performance assessment. The lead finding here is:
"Principles and techniques currently applied for assessing and
monitoring the quality of tests performed in the hospital laboratory are
directly applicable to home testing and physician office laboratory
practice.

"Provisions for achieving operational simplicity for home and
office testing must include the ability to monitor and maintain test
reliability."

The panel also advises that clinicians have an "ethical and
moral responsibility" to make sure that quality of care is not
compromised by geographic location of the test. Further, industry must
be active in protecting test reliability; ongoing education should be
maintained in physician labs; and careful attention to procedural and
interpretive instructions should accompany the growth in home testing.

*Procedural selection. Standing recommendations here are: 1)
Clinical usefulness and not market forces or technology should guide
procedural selection for distributive labs. 2) Site-dependent
validation of test or technology should be generally available prior to
procedural selection. 3) Selection of procedures for distributive labs
requires a specific analysis of each individual setting. 4)
Implementation of tests or technology for distributive labs should
include a defined program for quality assurance.

Some recently added assumptions andconclusions are that the easier
tests are to perform, the more quickly they will be used; procedural
selection is ultimately judged by clinical usefulness; patient
expectations and "need to know" are driving forces for change;
and assessment of cost should not be limited to direct dollar costs
alone.

This work group has also added a chart of requirements essential to
quality assurance at various stages in the testing chain. Research:
Quantify validity, reproducibility, and clinical usefulness. Industry:
Quantify the degree to which it meets manufacturer claims and expand on
clinical usefulness model. Clinical laboratory: Quantify the ability of
office laboratory personnel to obtain acceptable test results.
Distributive testing: Quantify the ability of the general public to
obtain acceptable results the first time.

The will of Congress and the Administration will be directly
influenced by such private-sector initiatives as the CAP's.
Perceived problems affecting constituents traditionally draw knee-jerk
resonses from politicians as Washington gears up--yes, already--for the
1988 elections.

COPYRIGHT 1987 Nelson Publishing
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